510(k) clearances

SonoTAP and SonoTAP II

PAJUNK GmbH Medizintechnologie · Anesthesiology

K243525Substantially EquivalentTraditionalBSP
Open FDA's page for this record
Third party flag
N
City
Geisingen
Advisory committee description
Anesthesiology
Address 1
Karl-Hall-Str. 1
Address 2
Pajunkstr. 1
Statement or summary
Summary
Product code
BSP
Zip code
78187
Applicant
PAJUNK GmbH Medizintechnologie
Decision date
2025-03-24
Decision code
SESE
Country code
DE
Device name
SonoTAP and SonoTAP II
Advisory committee
AN
Contact
Christian Quass
K number
K243525
Date received
2024-11-14
Review advisory committee
AN
Postal code
78187
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Medical specialty description
Anesthesiology
Regulation number
868.5150
Device class
2
Registration number
3006787036, 3000268902, 3013298431, 3015058854, 3030626857, 1061124, 3009518015, 3006425876, 1055236, 9616567, 3010321647, 3011625895, 3004111573, 3043226252, 3011137372, 1000587249, 3044026004, 3006271008, 3013764800, 9611612, 1420054, 3006260740, 9610993, 3001124136, 3012334073, 3010592727, 1625425, 9680794, 2523676, 9610825, 3011237770, 3048101437, 3010131137, 2025816, 1417592, 9680425, 3009039068, 3012421607, 1018470, 1820334 +95 more
FEI number
3006787036, 3000268902, 3013298431, 3015058854, 3009384766, 3030626857, 3002807847, 3009518015, 3006425876, 3932, 3002807091, 3010321647, 3011625895, 3003803331, 3002806575, 3004111573, 3043226252, 3000206435, 1000587249, 3044026004, 3006271008, 2649711, 3013764800, 1420054, 3006260740, 3001124136, 3012334073, 3001738911, 3010592727, 1625425, 1000138054, 3003076831, 2523676, 3011237770, 3048101437, 3010131137, 2025816, 1417592, 3009039068, 3012421607 +95 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.